Revelation Biosciences, Inc.: Form 10-Q for the period ended Jun 30, 2026

You should read the following discussion of our financial condition and results of operations in conjunction with our audited financial statements and the notes included elsewhere in this Form 10-Q. The following discussion contains forward-looking statements that involve certain risks and uncertainties. Our actual results could differ materially from those discussed in these statements. Factors that could cause or contribute to these differences include those discussed below and elsewhere in this Form 10-Q, the Company’s Form 10-K for the fiscal year ended December 31, 2025 and in the Company’s registration statements filed under the Securities Act of 1933, as amended, particularly under the “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements and Risk Factors Summary” sections.

Overview

Revelation is a clinical-stage life science company developing innovative solutions to treat acute and chronic disease. We are developing a pipeline of potential high-value products based on Gemini. Gemini is our proprietary formulation of PHAD, an established TLR4 agonist that can stimulate the human body’s innate immune response to prevent and treat disease. Our current Gemini programs consist of: GEM-AKI, which is being developed as a potential therapy for the treatment of acute kidney injury; and GEM-CKD, which is being developed as a potential therapy for the treatment of chronic kidney disease (together the “Product Candidates”).

Since our inception, we have devoted substantially all of our resources to organizing and staffing our Company, business planning, raising capital, and research and development of the Product Candidates.

We have funded our operations since our inception to June 30, 2026 through the issuance and sale of our capital stock, from which we have raised net proceeds of $75.9 million. Our current cash and cash equivalents balance will not be sufficient to complete all necessary product development or future commercialization efforts. We anticipate that our current cash and cash equivalents balance will not be sufficient to sustain operations within one-year after the date that our unaudited condensed consolidated financial statements for June 30, 2026 were issued, which raises substantial doubt about our ability to continue as a going concern.

We plan to seek additional funding through public or private equity or debt financings. We may not be able to obtain financing on acceptable terms, or at all. The terms of any financing may adversely affect the holdings or the rights of our stockholders. If we are unable to obtain funding we could be required to delay, reduce or eliminate research and development programs, product portfolio expansion or future commercialization efforts, which could adversely affect our business operations.

We have incurred recurring losses since our inception, including a net loss of $6.3 million for the six months ended June 30, 2026 and $4.5 million for the six months ended June 30, 2025. As of June 30, 2026 we had an accumulated deficit of $55.8 million. We expect to continue to generate operating losses and negative operating cash flows for the foreseeable future if and as we:

• continue the research and development of our product candidates;
• initiate clinical studies for, or preclinical development of, our product candidates;
• further develop and refine the manufacturing processes of our product candidates;
• change or add manufacturers or suppliers of product candidate materials;
• seek regulatory and marketing authorizations for any of our product candidates that successfully complete development;
• acquire or license other product candidates, technologies or biological materials;
• make milestone, royalty or other payments under future license agreements;
• obtain, maintain, protect and enforce our intellectual property portfolio;
• seek to attract and retain new and existing skilled personnel;
• create additional infrastructure to support our operations as a public company and incur increased legal, accounting, investor relations and other expenses; and
• experience delays or encounter issues with any of the above.

Our net losses may fluctuate significantly from quarter-to-quarter and year-to-year, depending on the timing of our clinical studies and our expenditures on other research and development activities.

We have never generated revenue and do not expect to generate revenue from product sales unless and until we successfully complete development and obtain regulatory approval for Product Candidates or other product candidates, which we expect will not be for at least several years, if ever. Accordingly, until such time as we can generate significant revenue from sales of Product Candidates or other product candidates, if ever, we expect to finance our cash needs through a combination of public or private equity offerings, debt financings or other capital sources, including potential collaborations, licenses and other similar arrangements. However, we may be unable to raise additional funds or enter into such other arrangements when needed on favorable terms or at all. Our failure to raise capital or enter into such other arrangements when needed would have a negative impact on our financial condition and could force us to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.

Recent Developments

Stockholder Rights Plan

On July 10, 2026, the Board of Directors of the Company adopted a stockholder rights plan and entered into a Rights Agreement (the “Rights Agreement”) with Continental Stock Transfer & Trust Co. Pursuant to the Rights Agreement, the Company declared a dividend of one preferred share purchase right (a “Right”) for each outstanding share of the Company’s common stock, payable to stockholders of record at the close of business on July 21, 2026 (the “Record Date”). The Rights will become exercisable only if a person or a group of affiliated or associated persons has become an “Acquiring Person,” which is defined in the Rights Agreement as a person or group of affiliated or associated persons who acquires or obtains the right to acquire beneficial ownership of 10% or more of the Company’s outstanding common stock (15% in the case of a person who reports their beneficial ownership on Schedule 13G) without the prior approval of the Board of Directors. In that case, each holder of a Right will be entitled to purchase one one-thousandth of a share of the Company’s Series B Preferred at a price of $20, subject to adjustment. The Rights are not exercisable until the Distribution Date, which is the earlier of (i) ten calendar days after a public announcement that a person has become an Acquiring Person and (ii) ten business days after the commencement of a tender or exchange offer that would result in a person becoming an Acquiring Person. In addition, the Rights Agreement has customary flip-in, flip-over and exchange features, and the Board of Directors may redeem all of the Rights at a price of $0.001 per Right, at any time before a person becomes an Acquiring Person. The Rights expire on the first anniversary of the Rights Agreement unless the Company’s stockholders ratify the Rights Agreement before that date, in which case the Rights expire on the third anniversary of the date of such approval, in each case subject to earlier redemption or exchange.

Reverse Stock Splits

On January 28, 2026, the Company effected a 1-for-4 reverse stock split of our outstanding shares of common stock, which had been approved at the 2025 annual meeting of stockholders on June 23, 2025. All share numbers included herein have been adjusted to reflect this reverse split.

Class I Warrant Inducement

On January 23, 2026, the Company entered into warrant inducement offer letters with two holders of 2,136,251 Class I Common Stock Warrants, exercisable for 2,136,251 shares of common stock with an exercise price of $8.80 per share of common stock. Pursuant to the warrant inducement offer letters, the holders agreed to the immediate cash exercise of their 2,136,251 Class I Common Stock Warrants to purchase an aggregate of 2,136,251 shares of the Company’s common stock at an exercise price of $3.44 per share, and the Company’s agreement to issue 4,272,500 Class J Common Stock Warrants exercisable for a total of up to 4,272,500 shares of common stock, at an exercise price of $3.44. The Company received net proceeds of approximately $6.7 million from the warrant exercises.

Research and Development

Research and development expenses consist primarily of costs incurred for the development of our product candidates. Our research and development expenses consist primarily of external costs related to clinical development, costs related to contract research organizations, costs related to consultants, costs related to acquiring and manufacturing clinical study materials, costs related to contract manufacturing organizations and other vendors, costs related to the preparation of regulatory submissions, costs related to laboratory supplies and services, and personnel costs. Personnel and related costs consist of salaries, employee benefits and stock-based compensation for personnel involved in research and development efforts.

We expense all research and development expenses in the periods in which they are incurred. We accrue for costs incurred as the services are being provided by monitoring the status of specific activities and the invoices received from our external service providers. We adjust our accrual as actual costs become known.

We expect our research and development expenses to increase substantially for the foreseeable future as we continue the development of Product Candidates and continue to invest in research and development activities. The process of conducting the necessary clinical research and product development to obtain regulatory approval is costly and time consuming, and the successful development of Product Candidates and any future product candidates is highly uncertain. To the extent that our product candidates continue to advance into larger and later stage clinical studies, our expenses will increase substantially and may become more variable.

The actual probability of success for Product Candidates or any future product candidate may be affected by a variety of factors, including the safety and efficacy of our product candidates, investment in our clinical programs, manufacturing capability, regulatory and staffing developments at the FDA and competition with other products. As a result, we are unable to determine the timing of initiation, duration and completion costs of our research and development efforts or when and to what extent we will generate revenue from the commercialization and sale of Product Candidates or any future product candidate.

General and Administrative

Our general and administrative expenses consist primarily of personnel costs, expenses for outside professional services, including financial advisory, legal, human resource, audit and accounting services and consulting costs. Personnel and related costs consist of salaries, employee benefits and stock-based compensation for personnel involved in executive, finance and other administrative functions. We expect our general and administrative expenses to increase for the foreseeable future as we increase the size of our administrative function to support the growth of our business and support our continued research and development activities. We also anticipate increased expenses as we continue to operate as a public company, including increased expenses related to financial advisory services, audit, legal, regulatory, investor relations costs, director and officer insurance premiums associated with maintaining compliance with exchange listing and SEC requirements.

Other Income (Expense), Net

Other income (expense), net primarily consists of interest income from our cash balances in savings accounts and foreign currency transaction gains and losses, in addition to other gains or losses resulting from transactions that do not relate to our continuing operations, if any.

Results of Operations

The following table summarizes our results of operations for the periods presented:

21

Research and Development Expenses

The following table summarizes our research and development expenses for the periods presented:

Research and development expenses increased by $0.6 million, from $1.3 million for the three months ended June 30, 2025 to $1.9 million for the three months ended June 30, 2026. The increase was primarily due to increases of $0.7 million in program expenses related to GEM-AKI, $0.2 million in manufacturing expenses related to GEM-AKI, $0.1 million of other expenses related to the new facility, and $0.1 million in personnel expenses, offset by a $0.5 million decrease in program expenses related to GEM-CKD.

Research and development expenses increased by $1.1 million, from $2.2 million for the six months ended June 30, 2025 to $3.3 million for the six months ended June 30, 2026. The increase was primarily due to increases of $0.7 million in program expenses related to GEM-AKI, $0.5 million in manufacturing expenses related to GEM-AKI, $0.3 million of other expenses primarily related to the new facility, and $0.2 million in personnel expenses, offset by a $0.6 million decrease in program expenses related to GEM-CKD.

General and Administrative Expenses

General and administrative expenses increased by $0.6 million, from $1.1 million for the three months ended June 30, 2025 to $1.7 million for the three months ended June 30, 2026. The increase was primarily due to increases of $0.5 million in personnel expenses, including stock-based compensation, and $0.1 million in professional fees.

General and administrative expenses increased by $1.1 million, from $2.4 million for the six months ended June 30, 2025 to $3.5 million for the six months ended June 30, 2026. The increase was primarily due to increases of $0.8 million in personnel expenses, including stock-based compensation, and $0.3 million in professional fees and costs related to the new facility lease.

Other Income (Expense), Net

Other income (expense), net, increased by $0.3 million, from $17,000 for the three months ended June 30, 2025 to $0.3 million for the three months ended June 30, 2026. The increase was primarily due to a refund received from the state of Delaware for overpaid franchise fees totaling $0.3 million.

Other income (expense), net, increased by $0.4 million, from $0.1 million for the six months ended June 30, 2025 to $0.4 million for the six months ended June 30, 2026. The increase was primarily due to a refund received from the Delaware Secretary of State for overpaid franchise fees totaling $0.3 million, and an increase of $0.1 million in interest income from our cash balances in savings accounts.

Liquidity and Capital Resources

Since our inception to June 30, 2026, we have funded our operations from the issuance and sale of our common stock, preferred stock and warrants, from which we have raised net proceeds of $75.9 million. As of June 30, 2026, we had available cash and cash equivalents of $11.5 million and an accumulated deficit of $55.8 million.

Our use of cash is to fund operating expenses, which consist primarily of research and development expenditures related to our Product Candidates or other product candidates. We plan to increase our research and development expenses substantially for the foreseeable future as we continue the clinical development of our current and future product candidates. At this time, due to the inherently unpredictable nature of product development, we cannot reasonably estimate the costs we will incur and the timelines that will be required to complete development, obtain marketing approval, and commercialize our current product candidate or any future product candidates. For the same reasons, we are also unable to predict when, if ever, we will generate revenue from product sales or any future license agreements which we may enter into or whether, or when, if ever, we may achieve profitability. Clinical and preclinical development timelines, the probability of success, and development costs can differ materially from expectations. In addition, we cannot forecast the timing and amounts of milestone, royalty and other revenue from licensing activities, which future product candidates may be subject to future collaborations, when such arrangements will be secured, if at all, and to what degree such arrangements would affect our development plans and capital requirements.

We expect to continue to generate substantial operating losses for the foreseeable future as we expand our research and development activities. We will continue to fund our operations primarily through utilization of our current financial resources and through additional raises of capital.

To the extent that we raise additional capital through partnerships or licensing arrangements with third parties, we may have to relinquish valuable rights to our product candidates, future revenue streams or research programs or to grant licenses on terms that may not be favorable to us. If we raise additional capital through public or private equity offerings, the ownership interest of our then-existing stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect our stockholders’ rights. If we raise additional capital through debt financing, we may be subject to covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we are unable to obtain adequate financing when needed, we may have to delay, reduce the scope of or suspend one or more of our clinical studies or preclinical studies, research and development programs or commercialization efforts or grant rights to develop and market our product candidates even if we would otherwise prefer to develop and market such product candidates ourselves.

Going Concern

We have incurred recurring losses since our inception, including a net loss of $6.3 million for the six months ended June 30, 2026. As of June 30, 2026 we had an accumulated deficit of $55.8 million, a stockholders’ equity of $10.1 million and available cash and cash equivalents of $11.5 million. We expect to continue to incur significant operating and net losses, as well as negative cash flows from operations, for the foreseeable future as we continue to complete all necessary product development or future commercialization efforts. We have never generated revenue and do not expect to generate revenue from product sales unless and until we successfully complete development and obtain regulatory approval for the Product Candidates or other product candidates, which we expect will not be for at least several years, if ever. We do not anticipate that our current cash and cash equivalents balance will be sufficient to sustain operations within one year after the date that our unaudited financial statements for June 30, 2026 were issued, which raises substantial doubt about our ability to continue as a going concern.

To continue as a going concern, we will need, among other things, to raise additional capital resources. We plan to seek additional funding through public or private equity or debt financings. We may not be able to obtain financing on acceptable terms, or at all. The terms of any financing may adversely affect the holdings or the rights of our stockholders. If we are unable to obtain funding we could be required to delay, reduce or eliminate research and development programs, product portfolio expansion or future commercialization efforts, which could adversely affect our business operations.

The unaudited condensed consolidated financial statements for June 30, 2026, have been prepared on the basis that we will continue as a going concern, and do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classification of liabilities that may result from the possible inability for us to continue as a going concern.

Cash Flows

The following table summarizes our cash flows for the periods presented:

Net Cash Used in Operating Activities

During the six months ended June 30, 2026, net cash used in operating activities was $5.8 million, which consisted of a net loss of $6.3 million, adjusted for non-cash items of $1.0 million, including stock-based compensation expense, non-cash lease expense and depreciation expense, and a net change of $0.4 million in our net operating assets and liabilities.

During the six months ended June 30, 2025, net cash used in operating activities was $4.7 million, which consisted of a net loss of $4.5 million, adjusted for non-cash items of $0.2 million, including the change in fair value of the warrant liability, stock-based compensation expense and depreciation expense, and a net change of $0.5 million in our net operating assets and liabilities.

Net Cash Used in Investing Activities

During the six months ended June 30, 2026, net cash used in investing activities consisted of the purchase of property and equipment.

During the six months ended June 30, 2025, there was no net cash provided by or used in investing activities.

Net Cash Provided by Financing Activities

During the six months ended June 30, 2026, net cash provided by financing activities was $6.7 million and was due to net proceeds received from the Class I Warrant Inducement in January 2026.

During the six months ended June 30, 2025, net cash provided by financing activities was $3.4 million from the May 2025 Public Offering.

Contractual Obligations and Other Commitments

We enter into contracts in the normal course of business with third party service providers and vendors. These contracts generally provide for termination on notice and, therefore, are cancellable contracts and not considered contractual obligations and commitments. We believe that our non-cancelable obligations under these agreements are not material.

Off-Balance Sheet Arrangements

As of June 30, 2026, we did not have any off-balance sheet arrangements.

Quantitative and Qualitative Disclosure about Market Risk

We are exposed to market risks in the ordinary course of our business.

Critical Accounting Policies and Significant Judgments and Estimates

Our management’s discussion and analysis of our financial condition and results of operations is based on our financial statements, which have been prepared in accordance with the generally accepted accounting principles in the United States (“GAAP”). The preparation of the consolidated financial statements in accordance with GAAP requires management to make estimates and assumptions about future events that affect the amounts of assets and liabilities reported, disclosures about contingent assets and liabilities, and reported amounts of revenue and expenses. These estimates and assumptions are based on management’s best estimates and judgment. Management regularly evaluates its estimates and assumptions using industry experience and other factors; however, actual results could differ materially from these estimates and could have an adverse effect on our consolidated financial statements. As of June 30, 2026, there have been no material changes to our existing critical accounting policies and estimates discussed in Part II, Item 7 of our Annual Report on Form 10-K for the year ended December 31, 2025.

Recent Accounting Pronouncements

See Note 2 to our unaudited condensed consolidated financial statements for more information about recent accounting pronouncements, the timing of their adoption, and our assessment, to the extent we have made one yet, of their potential impact on our financial condition or results of operations.

We are a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and are not required to provide the information otherwise required under this item.

Evaluation of Disclosure Controls and Procedures

Our management, with the participation of our principal executive officer and our principal financial officer, evaluated, as of the end of the period covered by this Quarterly Report on Form 10-Q, the effectiveness of our disclosure controls and procedures. Based on that evaluation of our disclosure controls and procedures as of June 30, 2026, our principal executive officer and principal financial officer concluded that our disclosure controls and procedures as of such date are effective at the reasonable assurance level. The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act are recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by us in the reports we file or submit under the Exchange Act is accumulated and communicated to our management, including our principal executive officer and principal financial officer, as appropriate to allow timely decisions regarding required disclosure. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives, and our management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures.

Changes in Internal Control over Financial Reporting

There was no change in our internal control over financial reporting that occurred during our most recent quarter that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

Our business is subject to various risks, including those described below and in Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2025.

A newly adopted Nasdaq rule could result in the delisting of the Company’s securities.

Revelation’s common stock and Public Warrants are listed on the Nasdaq Capital Market listing tier (“Nasdaq Capital Market”) under the symbols “REVB” and “REVBW,” respectively. In general, if Nasdaq delists the Revelation common stock and Public Warrants from trading on its exchange for failure to meet the listing standards such as the minimum public stockholders equity requirement, minimum bid price, minimum market value of publicly-held shares, for failure to hold an annual stockholders meeting, or any other listing standards, we and our stockholders could face significant material adverse consequences including:

• limited availability of market quotations for our securities;
• reduced liquidity for Revelation’s securities;
• a determination that the Revelation common stock is a “penny stock” which will require brokers trading in the Revelation common stock to adhere to more stringent rules and possibly result in a reduced level of trading activity in the secondary trading market for Revelation’s securities;
• a limited amount of news and analyst coverage; and
• a decreased ability to issue additional securities or obtain additional financing in the future.

On or about July 23, 2026, the SEC allowed a new Nasdaq continued listing rule to come into effect (the “MVLS Rule”) that requires automatic delisting if the market value of a company's listed securities remains below $5 million for 30 consecutive business days. The new MVLS Rule eliminates any cure period, precludes any automatic stay of suspension pending an appeal, and results in an immediate trading suspension upon Nasdaq's determination of non-compliance. Given that the current market value of the Company’s listed securities is below $5 million, the MVLS Rule would result in the delisting of the Company’s securities from Nasdaq should the market value of its listed securities remain below $5 million for 30 consecutive business days. Prior to its implementation, however, the MVLS Rule was automatically stayed pending further action by the SEC. Accordingly, it is currently uncertain when the stay will be lifted, or the MVLS Rule delayed, modified, or set aside. The Company is in active discussions with its financial and legal advisors to address the manner in which it could achieve compliance with the MVLS Rule, if at all, should it be implemented in generally the same form as it had been originally adopted. There can be no assurances, however, that if the stay is lifted and the MVLS Rule goes into effect as originally adopted, the Company’s efforts to avoid delisting will be successful.

We have recently adopted a Rights Agreement that includes terms and conditions that could discourage a takeover or other transaction that stockholders may otherwise consider favorable.

In recognition of the risk that an opportunist acquiror may attempt to take over the Company at a price that does not reflect the full value of the Company’s development pipeline, on July 10, 2026, the Board adopted a stockholder rights plan (the “Rights Plan”) pursuant to which stockholders of record as of the close of business on July 21, 2026 are to receive one preferred share purchase right (each, a “Right”) for each outstanding share of Common Stock they beneficially own. Each Right entitles the registered holder to purchase from the Company one one-thousandth of a share of Series B Junior Participating Preferred Stock (the “Preferred Stock”), of the Company at an exercise price of $20.00, subject to adjustment. Under the Rights Agreement, the Rights will become exercisable if a person or group acquires beneficial ownership of 10% or more of the Company’s outstanding Common Stock (15% for qualifying passive investors that file on Schedule 13G) without the prior approval of the Board, or if a person or group with beneficial ownership of 10% or more at the time the adoption of the Rights Agreement is announced acquires any additional shares of Common Stock, without the prior approval of the Board. In the event that the Rights become exercisable due to such thresholds being triggered or certain other triggers, each Right will entitle its holder to purchase, at the Right’s exercise price, a number of shares of common stock or equivalent securities (including the Common Stock or equivalent securities of an acquiring entity after a change of control upon certain triggers) having a market value at that time equal to twice each Right’s exercise price.

The Board adopted the Rights Agreement to protect the interests of Company stockholders. In general terms, subject to certain enumerated exceptions, it works by imposing significant dilution upon any person or group that acquires beneficial ownership of 10% or more of the shares of Common Stock, or if a person or group with beneficial ownership of 10% or more at the time the adoption of the Rights Agreement is announced acquires any additional shares of Common Stock, without the prior approval of the Board. In general, any person will be deemed to beneficially own any securities (a) as to which such person has any agreement, arrangement or understanding with another person for the purpose of acquiring, holding, voting or disposing of any shares of Common Stock or (b) that are the subject of a derivative transaction or constitute a derivative security. As a result, the overall effect of the Rights Agreement and the issuance of the Rights may be to render more difficult or discourage a merger, tender or exchange offer or other business combination involving the Company that is not approved by the Board. However, neither the Rights Agreement nor the Rights should interfere with any merger, tender or exchange offer or other business combination approved by the Board.

The Rights Agreement is similar to agreements adopted by other public companies in comparable circumstances. It is intended to enable all Company stockholders to realize the full value of their investment and to reduce the likelihood that any person or group gains control of the Company through open-market accumulation or other coercive or unfair tactics without paying an appropriate control premium to all stockholders. It is designed to protect stockholders’ interests, by, among others, providing the Board sufficient time to make informed judgments and take actions that are in the best interests of all of the Company’s stockholders and other stakeholders. Nevertheless, the Rights Agreement may be considered to have certain anti-takeover effects, including potentially discouraging a third party from attempting to obtain a substantial position in the Common Stock or seeking to obtain control of the Company and discouraging a takeover attempt that stockholders may consider favorable or that could result in a premium over the market price of the Common Stock. Even in the absence of a takeover attempt, the Rights Agreement may adversely affect the prevailing market price of the Common Stock if it is viewed as discouraging takeover attempts in the future. The Company cannot predict, and no assurances can be given as to, the outcome or timing of any matters relating to the foregoing actions by activist stockholders and its responses thereto or the ultimate effects on its business, liquidity, financial condition, or results of operations.

We will require substantial additional financing to continue our operations, which may not be available on acceptable terms or at all, and any future financing may cause substantial dilution to our stockholders.

Drug development is a lengthy, expensive, and uncertain process. We have incurred significant operating losses since our inception, and we expect to continue to incur substantial net losses for the foreseeable future as we advance our product candidates through preclinical and clinical development, seek regulatory approvals, and build our commercial infrastructure. We do not currently have any products approved for sale, and we do not generate any revenue from product sales. As a result, we are entirely dependent on external financing to fund our operations.

We will require substantial additional capital to continue to operate in accordance with our business plan, including to fund ongoing and planned research and development activities, conduct clinical trials, support regulatory submissions, maintain and expand our intellectual property portfolio, and for working capital and general corporate purposes. The amount and timing of our future funding requirements will depend on many factors, some of which are beyond our control, including the progress, costs, and results of our clinical and preclinical programs; the outcome of regulatory review of our product candidates; the cost and timing of establishing sales and marketing capabilities; and market conditions generally.

We cannot assure you that additional financing will be available when needed or, if available, that it will be available on terms that are acceptable to us. If we are unable to raise capital when needed or on acceptable terms, we could be forced to delay, reduce, or eliminate our research and development programs or other operations, which could have a material adverse effect on our business, financial condition, and results of operations.

To the extent we raise additional capital through the issuance of equity or equity-linked securities—including common stock, preferred stock, warrants, or convertible instruments—our existing stockholders will experience dilution. Such dilution may be substantial. In addition, certain of our outstanding securities contain anti-dilution provisions that are triggered by future issuances of equity at prices below the existing conversion or exercise prices. To the extent such provisions are triggered, holders of those securities may have their conversion or exercise prices adjusted to the new offering price, resulting in further dilution to our other stockholders beyond what would otherwise occur. The terms of any future financing may also include covenants or other restrictions that limit our operational flexibility. There can be no assurance that we will be able to obtain the financing necessary to continue our operations on terms acceptable to us, if at all, and our failure to do so could have a material adverse effect on our business and the value of our securities.